Rehabilitation at Home Using Mobile Health In Older Adults After Hospitalization for Ischemic Heart Disease

  • STATUS
    Recruiting
  • End date
    Apr 26, 2024
  • participants needed
    400
  • sponsor
    NYU Langone Health
Updated on 26 January 2021
heart disease
bypass graft
cardiac rehabilitation
rehabilitation program
rehabilitation therapy

Summary

RESILIENT is a phase II, multi-center, prospective, pragmatic randomized clinical trial with blinded assessment of the primary endpoint. This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age 70) with IHD compared with standard traditional cardiac rehabilitation care. A total of 400 eligible patients will be randomized in 3:1 manner to mHealth-CR versus usual care for assessment of primary endpoint. Enrollment will occur over approximately 42 months with an expected minimum of 3 months follow-up per participant.

Description

The primary objective of RESILIENT is to evaluate whether mobile health cardiac rehab (mHealth-CR) improves functional capacity in older adults (age 70) with ischemic heart disease (IHD), identified at the time of acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG), compared with usual care. Our central hypotheses related to efficacy are that mHealth-CR will (1) improve functional capacity (primary outcome), (2) improve goal attainment, health status, and activities of daily living, and (3) lower rates of hospital readmission and death (secondary outcomes). Our central hypothesis related to engagement is that we will identify distinct trajectories of engagement and characteristics that predict membership in each category.

Details
Condition Vascular Diseases, Heart disease, Ischemic Heart Disease, Cardiac Ischemia, Myocardial Ischemia, Cardiac Disease
Treatment Usual Care, mHealth-CR
Clinical Study IdentifierNCT03978130
SponsorNYU Langone Health
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 65 yrs and 110 yrs?
Gender: Male or Female
Do you have any of these conditions: Myocardial Ischemia or Vascular Diseases or Ischemic Heart Disease or Cardiac Ischemia or Cardiac Disease or Heart disease?
Do you have any of these conditions: Myocardial Ischemia or Cardiac Disease or Vascular Diseases or Cardiac Ischemia or Heart disease or Ischemic Heart Disease?
Do you have any of these conditions: Ischemic Heart Disease or Heart disease or Cardiac Disease or Vascular Diseases or Myocardial Ischemia or Cardiac Ischemia?
Do you have any of these conditions: Heart disease or Cardiac Disease or Cardiac Ischemia or Myocardial Ischemia or Vascular Diseases or Ischemic Heart Disease?
Age 65
Currently hospitalized for AMI, PCI, or CABG or Hospitalized for AMI, PCI or CABG within prior 2 weeks
Capable of self-consent
Understand and are able to perform study procedures (i.e. 6-minute walk test, use mHealth in English or Spanish)

Exclusion Criteria

Non-ambulatory
Moderate or severe cognitive impairment
Unable/unwilling to consent
PCI-related groin hematoma that precludes brisk walking
Incarcerated
Unable to use mHealth software in English or Spanish
Severe osteoarthritis, or joint replacement within last 3 months
Parkinson's disease or other progressive movement disorder
Regular use of walker for ambulation
Projected life expectancy <3 months
Clinical judgment concerning other safety or nonadherence issues
Participants admitted from long-term care facility
Currently listed for heart transplant
Left ventricular assist device recipient
Completion of ambulatory cardiac rehabilitation program within prior 3 months
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